Deep Brain Stimulation for Severe Bipolar Depression

Building Mood State Classifiers to Inform Deep Brain Stimulation of Treatment-Resistant Bipolar Depression

This study is testing whether Deep Brain Stimulation can help people with severe bipolar depression who haven't found relief from other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years to 64 Years
• Sex: All
• Sponsor: Baylor College of Medicine (other)
• Locations: 4 sites (Boston, Massachusetts and 3 other locations)
• Trial ID: NCT06599099 on ClinicalTrials.gov

What this trial studies

This research investigates the use of Deep Brain Stimulation (DBS) to improve symptoms of Treatment-Resistant Bipolar Depression (TRBD) in patients with severe cases. The study involves surgical implantation of electrodes in specific brain areas to restore balance to dysfunctional brain circuitry. Participants will undergo a thorough screening process, including medical evaluations and imaging, before receiving the DBS intervention. The goal is to enhance current DBS targeting methods and develop a more reliable treatment for TRBD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22-64 with a diagnosis of Bipolar I disorder currently experiencing a major depressive episode and who have not responded to multiple evidence-based treatments.

Not a fit: Patients who do not have a diagnosis of Bipolar I disorder or who have not experienced treatment-resistant symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from severe bipolar depression that has not responded to traditional therapies.

How similar studies have performed: Other studies using Deep Brain Stimulation for various psychiatric conditions have shown promising results, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Males and females ages 22-64, inclusive
2. Diagnosis: Bipolar I disorder confirmed by SCID-5, currently in a major depressive episode (MDE).
3. Symptom Severity: MADRS score of ≥27 at Screening and pre-operative baseline visit. CGI-S \> 4 and YMRS \<12 at these visits.
4. Failure to respond or maintain a response to a minimum of four evidence-based interventions for bipolar depression in the patient's lifetime, including at least two FDA-approved medications (olanzapine/fluoxetine, quetiapine, lurasidone, cariprazine, lumateperone), or ECT, administered at adequate doses and duration (adequately defined by the Antidepressant Treatment History Form (ATHF-Short Form). During the current episode, the patient must have failed to respond or maintain a response to a minimum of two FDA-approved interventions for bipolar depression. In addition, the patient is required to be currently taking at least one evidence-based medication for bipolar disorder (e.g., lithium, either alone or in combination with an atypical antipsychotic such as quetiapine), unless no evidence-based medications for bipolar disorder are tolerated.
5. Initial mood episode occurred before the age of 40 - to minimize risk of enrolling patients with so atypical onset of initial mania/depression.
6. Must be on a stable dose of psychotropic medications for a minimum of four weeks prior to surgery.
7. Minimum score on the Montreal Cognitive Assessment (MoCA).
8. Able and willing to give informed consent and sign Treatment Contract that includes identification of a reliable informant.

Exclusion Criteria:

1. Lifetime history of a psychotic disorder (e.g., schizophrenia, schizoaffective disorder, and other psychotic disorders), or any history of psychotic symptoms when not in a bipolar mood episode.
2. Currently meets criteria for a manic or hypomanic episode or rapid cycling (4 or more mood episodes in the previous 12 months).
3. Any psychiatric disorder which is the primary focus of treatment within the past 12 months (with bipolar disorder as the secondary focus of treatment).
4. Alcohol/substance use disorder, moderate or severe, within the previous 12 months \[excluding nicotine\].
5. Intellectual disability or neurocognitive disorder.
6. Current major and/or unstable medical conditions. e.g., liver insufficiency, kidney insufficiency, cardiovascular problems \[unstable arrhythmias, chronic heart failure, myocardial infarction (MI), cardiac pacemaker\], systemic infections, cancer, active upper respiratory infections, endocrinopathies, and any major neurological disorder \[e.g., seizure disorder, stroke, dementia, degenerative neurologic diseases, traumatic brain injury\].
7. Any medical contraindication to surgery or condition that makes the patient, in the opinion of the surgeon, a poor candidate.
8. Female who is pregnant or breastfeeding or has plans to become pregnant in the next 24 months.
9. Any contraindication for MRI.
10. Patients with a clinically significant personality disorder, including risk for homicidal or aggressive behavior, which in the opinion of the investigator has a major impact on the patient's current psychiatric status and/or would preclude safe study participation.
11. Patients at serious and imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigators.
12. Participation in any investigational clinical trial within the preceding 30 days.
13. Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators \[including deep brain and spinal cord stimulators\].
14. Patients with no regular contact with at least one adult. Patients who are undomiciled are excluded.
15. Body mass index (BMI) less than 16 and greater than 40 kg/m2
16. Need for diathermy.
17. Unable to sign the informed consent for any reason.
18. Patients who are not under the care of a psychiatrist at Screening and throughout the duration of the study.

Where this trial is running

Boston, Massachusetts and 3 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
• Baylor College of Medicine — Houston, Texas, United States (RECRUITING)
• Rice University — Houston, Texas, United States (ACTIVE_NOT_RECRUITING)
• University of Washington — Seattle, Washington, United States (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Wayne Goodman, MD — Baylor College of Medicine
• Study coordinator: Michelle Avendano

Conditions: Bipolar Depression, Treatment Resistant Bipolar Depression